The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study

NCT03010995 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 16.1079
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.

Conditions

Cigarette Smoking Toxicity; Nicotine; Acute Cardiovascular Disease

Keywords

electronic cigarette; endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Flow mediated dilatation

  Change between baseline and post exposure 20-30 mins

Secondary Outcomes (4)

• Heart rate

  Change between baseline and post exposure 5,10, 30, 60, 120 mins

• Blood pressure

  Change between baseline and post exposure 5,10, 30, 60, 120 mins

• Heart Rate Variability

  Change between baseline and post exposure 20 mins

• Nicotine levels in plasma

  Change between Baseline and over 2 hours

Study Arms (3)

18 mg nicotine

ACTIVE COMPARATOR

E-cigarette with 18 mg nicotine

Drug: Prazosin

9 mg nicotine

ACTIVE COMPARATOR

E-cigarette with 9 mg nicotine

Drug: Prazosin

0 mg nicotine

PLACEBO COMPARATOR

E-cigarette with 0 mg nicotine

Drug: Prazosin

Interventions

Prazosin DRUG

Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

0 mg nicotine; 18 mg nicotine; 9 mg nicotine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant will be currently healthy individuals, between 18 and 40 years of age.
• E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users
• Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.

You may not qualify if:

• Unwilling or unable to provide informed consent.
• Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma.
• Body weight less than 100 pounds or BMI \>40.
• Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
• Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
• Pregnant or lactating women.
• Prisoners and other vulnerable populations.
• Anyone that PI thinks is unsafe to participate in the study.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: January 5, 2017
• Study Start: March 13, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)